Defective Medical Devices – Pacemakers

The use of pacemakers, heart rhythm devices and defibrillators has increased by 49 per cent in the United States since 1990. However, in-line with the growth in the use of these devices, the number of recalls and safety alerts has also increased substantially. In fact, the FDA has already issued over 50 advisories on these devices since they were introduced to the market.

There are two types of devices that can be included in this category: implantable cardioverter-defribrillators (ICDs) and pacemakers. The incidences of failure and the number of FDA advisories are much higher for ICDs. The main reason is that ICDs are much more technically complex devices and thus more likely to fail or cause problems. Pacemakers are less prone to failure, but can have battery failure or, in one of the high profile cases involving St. Jude Medical, defective manufacturing. However, patients can also have medical problems associated with the implantation of these devices, such as a staph infection - which can be fatal.

Already, the economic costs associated with pacemaker, ICD and heart rhythm device recalls have totaled nearly $1 billion over the last 10 years. Obviously the costs associated with these devices are not only those resulting from the failure itself, but the medical costs associated with replacing the defective device. Patients can launch defective medical device suits against the manufacturer if they have been implanted with defective devices.